A 12 Week, Multicenter, Open Label Evaluation of Caregiver Preference, Safety and Tolerability of Exelon® Patch (Rivastigmine Transdermal) in Patients With Alzheimer's Disease (BETTER)

Novartis

Status and phase

Completed

Phase 4

Conditions

Alzheimer's Disease

Treatments

Drug: Rivastigmine transdermal

Study type

Interventional

Funder types

Industry

Identifiers

NCT01047579

CENA713DIL01

Details and patient eligibility

About

This study is designed to evaluate caregiver preference for Exelon® patch (target patch size 10 cm²) treatment in patients with Alzheimer's disease (MMSE 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.

Enrollment

51 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Probable Alzheimer's disease according to the NINCDS-ADRDA and DSM-IV criteria.
MMSE score of >10 and <26.
Patients who were under ChE inhibitor treatment and experienced adverse events.
Residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient.

Exclusion criteria

Involved in other clinical trials or treated by experimental drug within the previous 4 weeks.
Current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch.
History of allergy to topical products containing any of the constitution of the patches.
Patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc.
Patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree A-V blocks).
Patients with body weight less than 40 kg.

Other protocol-defined inclusion/exclusion criteria may apply